<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20201017049054N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-12-27</date_registration>
      <primary_sponsor>Sabzevar University of Medical Sciences</primary_sponsor>
      <public_title>The effect of lidocaine spray and ice spray on reducing injection pain</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of lidocaine spray and ice spray on the severity of pain during insertion of vascular needles in hemodialysis patients of the dialysis ward</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-12-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>48</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/52682</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Crossover, Purpose: Supportive, Other design features: Ice spray is a sports spray that is used temporarily during level one injuries (scratches, bruises, blows, strains and pressure) that has the property of cooling and temporarily reducing pain temporarily. Easy to use Availability, cheapness and quick effect and getting an effective result in case of sports accidents can be generalized to its use in the clinic, Randomization description: Individuals were selected by simple random sampling using a random number table until all the interventions were identified and finally placed in a group of 48 people. Each person has their own intervention and control. In order to determine which intervention or control each person will be placed in for the first time and the next time, a random number table is used. (For example, from above), then the numbers 0 to 24 are considered for intervention A, the numbers 25 to 49 are considered for intervention B and the numbers 50 to 74 are considered for intervention C. Then we touch one of the numbers and move in one of the predetermined directions and record the numbers and assign them to different interventions, Blinding description: The sprays are covered with a cover whose information is not disclosed and are separated by marks A, B and C. Also, in this case, the researcher himself does not make any intervention that causes the percentage of research error to decrease and is merely an observer of the work. The sprays are given to him. The patient and clinical caregiver are unaware of the contents of the spray used.</study_design>
      <phase>3</phase>
      <hc_freetext>Hemodialysis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention 1: 10% lidocaine spray (10% lidocaine local anesthetic spray Sina drug) is sprayed in two puffs (20 mg) from a distance of 20 cm on the desired location. Intervention 2: Intervention 2: Ice spray (Power Ice Delta Zex Company - Delta Drug Company) is sprayed in the amount of two puffs (2 cc) from a distance of 20 cm on the desired location. Intervention 3: Control: Alcohol spray (70% ethanol - Kimia Zanjan Alcoholic Company) is sprayed in the amount of two puffs (140 mg) from a distance of 20 cm on the desired location.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hamid Roudsarabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.5, Moalem Ave, Pasdaran blvd</address>
        <city>Sabzevar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9618738144</zip>
        <telephone>+98 51 4465 1401</telephone>
        <email>RoudsarabiH96@medsab.ac.ir</email>
        <affiliation>Sabzevar University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hamid Roudsarabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.5, Moalem Ave, Pasdaran blvd</address>
        <city>Sabzevar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9618738144</zip>
        <telephone>+98 51 4465 1401</telephone>
        <email>RoudsarabiH96@medsab.ac.ir</email>
        <affiliation>Sabzevar University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The patient is 18-65 years old.
The patient needs to be hospitalized and undergo dialysis with peripheral vascular needles.
The patient is aware of the time, place and person.
It is possible to place vascular needles for the patient.
Literacy for reading and writing.
No problems in terms of verbal, mental and visual abilities.
No opioid addiction or strong analgesics.
Lack of sensitivity to anesthetics.
No diabetes for more than 10 years.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The patient has a history of heart disease.
The patient has skin and vascular disorders (erythema, itching, bruising, etc.) at the site of needle entry.
The patient has symptoms of decreased sensation and movement in the upper limbs under catheterization.
The patient has disease-related pain.
The patient should take painkillers or narcotics before the venipuncture and be within the duration of the effect of these drugs.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z99.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Dependence on renal dialysis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention 1: 10% lidocaine spray (10% lidocaine local anesthetic spray Sina drug) is sprayed in two puffs (20 mg) from a distance of 20 cm on the desired location.</i_keyword>
      <i_keyword>Intervention 2: Ice spray (Power Ice Delta Zex Company - Delta Drug Company) is sprayed in the amount of two puffs (2 cc) from a distance of 20 cm on the desired location.</i_keyword>
      <i_keyword>Control: Alcohol spray (70% ethanol - Kimia Zanjan Alcoholic Company) is sprayed in the amount of two puffs (140 mg) from a distance of 20 cm on the desired location.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain score. Timepoint: For each person, the pain is measured immediately after each spray, and at the end of the study, each person determines their pain a total of three times (once for each spray). Method of measurement: Visual Analogue Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>by my own. Hamid Roudsarabi</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-12-01</approval_date>
        <contact_name>Ethics Committee of Sabzevar University of Medical Sciences</contact_name>
        <contact_address>Shohadaye Hasteyi Blvd, Sabzevar. Sabzevar Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
